FDA Finds PHOs Unsafe

Product Liability Update

Date: June 19, 2015

The U.S. Food and Drug Administration (FDA) recently announced its determination that partially hydrogenated oils (PHOs), the main dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. The oils are used for frying and in baked goods and confections. Hydrogenation makes oils more stable and solid at room temperature. The FDA’s stated reason for targeting trans fats is to reduce coronary heart disease in the United States. The agency’s recent action follows a 2013 tentative determination that PHOs could no longer be considered GRAS. Thereafter, the FDA considered public comments, reviewed scientific data and evidence, and found that there is no safe level for consumption of PHOs.

What does this mean for the U.S. food industry? Food manufacturers have a compliance period of three years to reformulate products to eliminate PHOs or request the FDA’s approval for their use in food. The final determination aims to considerably reduce the use of PHOs in the food supply, effectively minimizing industrial trans fats in the American diet by 2018. This means that after the compliance period, no PHOs can be added to human food unless they are approved by the FDA, and manufacturers would need to petition the FDA to permit specific uses of PHOs.

In its recent news release, the FDA stated that it encourages consumers seeking to reduce trans fat intake to review a food’s ingredient list to determine whether or not the food contains PHOs. Under the current labeling rules, a food product is permitted to be labeled as having 0 grams of trans fat if the food contains less than 0.5 grams of trans fat (including PHOs) per serving. This labeling requirement and increased consumer awareness has resulted in a significant decrease in consumer consumption of trans fat. The FDA also stated in its release that many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate trans fat ahead of the three-year compliance deadline.

The FDA estimates the cost for food manufacturers to comply may reach billions of dollars, possibly averaging hundreds of thousands of dollars per product. The compliance process potentially includes assessing product formulations, researching and testing viable alternatives, repackaging products, communicating with suppliers, and gathering data to petition the FDA to allow some uses of partially hydrogenated oils as needed.


For more information, please contact:

Neelam Gill

Walt A. Linscott

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